Beckman Coulter Inc. recalls MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in det…

Recall date

September 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0108-2016

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of Bahamas, Belgium, Canada, Ecuador, Germany, Italy, Republic of Korea, Mexico, Peru, Poland, Romania, Saudi Arabia, South Africa, Thailand, United Sates (including Puerto Rico), and Uruguay.

Why it was recalled

Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.